POS0640 REAL-WORLD EFFECTIVENESS AND SAFETY OF GP2015 IN PATIENTS WITH RHEUMATIC DISEASES: FINAL RESULTS OF THE COMPACT STUDY
Authors: M. Schmalzing, H. Kellner, A. Askari, J. De Toro Santos, J. C. Vazquez Perez-Coleman, R. Foti, S. Jeka, B. Haraoui, Y. Allanore, M. Rahman, F. Furlan, S. Hachaichi, T. Sheeran
Journal: Annals of the Rheumatic Diseases (2022)

Background COMPACT is a non-interventional study evaluating the effectiveness and safety in patients (pts) with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) treated with GP2015 (an etanercept [ETN] biosimilar) in real-world conditions. Objectives We present the effectiveness and safety data from the final analysis of the COMPACT study for all patient groups. Methods Pts aged ≥18 years on treatment with GP2015 were enrolled. Baseline visit corresponded with date of study inclusion and not with date of GP2015 treatment start. Pts were categorised based on prior treatment status: pts on clinical remission or low disease activity under treatment with reference ETN or biosimilar ETN (initial ETN: [iETN]) and switched to GP2015 (Group A) or pts who received non-ETN targeted therapies and switched to GP2015 (Group B) or biologic-naïve pts who started GP2015 after conventional therapy failure (Group C) or DMARD-naïve pts with recent diagnosis of RA considered suitable for treatment initiation with a biologic and started on treatment with GP2015 (Group D). Effectiveness assessments included Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) or Ankylosing Spondylitis Disease Activity Score (ASDAS) until Month 12 after enrolment (baseline) in the study. Results Of the 1466 pts enrolled, 572 were switched from iETN (Group A), 171 were switched from other targeted therapies (Group B), 713 were biologic-naïve (Group C), and 10 were RA DMARD-naïve (Group D). Comorbidities were more frequent in pts with RA (68.7%,) followed by pts with PsA (59.4%) and axSpA (52.1%). After 12 months of treatment with GP2015, pts with RA or PsA achieved comparable DAS28-ESR scores irrespective of whether they switched from iETN, or from other targeted therapies or were biologic-naïve. At Month 12, the mean ASDAS scores were comparable between the treatment groups in pts with axSpA (Table 1). Across all pt groups, no major differences were observed in the disease activity scores between baseline and Month 12 that may be explained by the ongoing GP2015 treatment at the time of enrolment for an observed average of 138 days. Overall, the proportion of patients with at least one adverse event (AE) and serious AE (SAE) was 47.6% and 7.7% in pts who were switched from iETN, 56.7% and 9.9% in pts switched from other targeted therapies, 56% and 8.7% in biologic-naïve pts, and 60% and 0% in DMARD-naïve pts. Rate of injection site reaction was low across the groups (Figure 1). Table 1. Effectiveness outcomes in patients treated with GP2015 Effectiveness outcomes Group A Group B Group C Group D Overall (A-D) RA DAS28-ESR, n, mean (SD) N=295 N=88 N=451 N=10 N=844 Baseline n=259 n=70 n=392 n=8 n=729 2.5 (1.1) 3.6 (1.3) 3.3 (1.5) 3.8 (1.2) 3.0 (1.4) Month 12 n=135 n=47 n=238 n=2 n=422 2.5 (1.3) 2.7 (1.0) 2.8 (1.4) 4.3 (2.5) 2.7 (1.3) PsA N=117 N=36 N=135 N=0 N=288 Baseline n=80 n=30 n=116 - n=226 2.1 (1.0) 2.9 (1.6) 2.9 (1.6) 2.6 (1.5) Month 12 n=32 n=13 n=60 - n=105 2.6 (1.9) 2.6 (1.6) 2.3 (1.4) 2.4 (1.5) AxSpA ASDAS, n, mean (SD) N=160 N=47 N=127 N=0 N=334 Baseline n=77 n=18 n=59 - n=154 1.6 (0.6) 1.8 (0.8) 2.3 (0.9) 1.9 (0.8) Month 12 n=39 n=8 n=23 - n=70 1.8 (0.9) 1.9 (0.6) 1.9 (1.0) 1.8 (0.9) N, total number of patients in the treatment group; n, number of patients with available data at each time point, SD, standard deviation Figure 1. Overall safety outcomes in patients treated with GP2015 Figure 1 represents the adverse events reported during GP2015 treatment. N, total number of patients in the treatment; n, number of patients in each treatment group Conclusion The results show comparable disease activity scores between pts who were switched from iETN, pts switched from other targeted therapies and biologic-naïve pts after 12 months of treatment with GP2015. No impact on the effectiveness of ETN was observed in pts with RA, axSpA or PsA who switched to GP2015. No new safety signals were reported. Disclosure of Interests Marc Schmalzing Speakers bureau: Novartis, AbbVie, Chugai/Roche, Janssen-Cilag, Lilly, Consultant of: AstraZeneca, Chugai/Roche, Hexal/Sandoz, Gilead, AbbVie, Janssen-Cilag, Boehringer/Ingelheim, Grant/research support from: Chugai/Roche, Boehringer/Ingelheim, Celgene, Medac, Herbert Kellner: None declared, Ayman Askari: None declared, Javier de Toro Santos: None declared, JULIO CESAR VAZQUEZ PEREZ-COLEMAN Speakers bureau: Sandoz, Abbvie, Sanofi, Fresenius, Rosario Foti Speakers bureau: Abbivie, Gilead, Lilly, Pfizer, UCB, Roche, Novartis, Pfizer, UCB, Sławomir Jeka: None declared, Boulos Haraoui Consultant of: Abbvie, Amgen, Fresenius Kabi, Lilly and Pfizer, Grant/research support from: Abbvie, Amgen, Fresenius Kabi, Lilly and Pfizer, Yannick Allanore Consultant of: Sandoz Hexal, Mylan, Astra-Zeneca, Masiur Rahman Employee of: Sandoz Hexal AG, Fabricio Furlan Employee of: Sandoz Hexal AG, Sohaib HACHAICHI Employee of: Sandoz Hexal AG, Tom Sheeran Speakers bureau: Pfizer, UCB, Roche, Consultant of: Novartis, Pfizer, Grant/research support from: Novartis, UCB, Roche